FHQ
7 FDA 510(k) clearances · Product code
56 daysmedian time to decision
463 days90th percentile
7clearances measured
FDA profile
- Official device name
- Holder, Needle, Gastroenterologic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2019: 80 · 2020: 50 · 2021: 57 · 2022: 64 · 2023: 63 · 2024: 69
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| WINGED NEEDLE HOLDER (K974327) | Phx Technologies Corp. | 1998-01-09 |
| LAPAROSCOPIC NEEDLE HOLDER (K924196) | Nusurg, Inc. | 1993-06-25 |
| ENDOSCOPIC NEEDLEHOLDER, MODIFICATION (K930330) | Holmed Corp. | 1993-06-08 |
| MAGNETIC POINT GUARD FOR SURGICAL NEEDLES (K920706) | Retrax | 1993-05-26 |
| 25-100,25-220 VARIOUS NEEDLE HOLDERS (K851779) | Artiberia | 1985-06-20 |
| 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS (K851780) | Artiberia | 1985-06-20 |
| NEEDLE HOLDER, MICROVASCULAR (K771859) | Edward Weck, Inc. | 1977-10-04 |
Track FHQ automatically
Every clearance here is in the API, with alerts when new ones post.